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WO2017214734A1 - Systèmes et procédés de montage de capteurs réglables à cavité fermée - Google Patents

Systèmes et procédés de montage de capteurs réglables à cavité fermée Download PDF

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Publication number
WO2017214734A1
WO2017214734A1 PCT/CA2017/050742 CA2017050742W WO2017214734A1 WO 2017214734 A1 WO2017214734 A1 WO 2017214734A1 CA 2017050742 W CA2017050742 W CA 2017050742W WO 2017214734 A1 WO2017214734 A1 WO 2017214734A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
assembly
closed cavity
adjustable
sensor mount
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CA2017/050742
Other languages
English (en)
Inventor
Frederick Allen Moore
Lesley Myron OTSIG
Muhammad Nasir Al-din Bin ZULKAFLY
Theodore Drew Fast HUSBY
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novadaq Technologies ULC
Original Assignee
Novadaq Technologies ULC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novadaq Technologies ULC filed Critical Novadaq Technologies ULC
Priority to EP17812366.7A priority Critical patent/EP3472570A4/fr
Priority to CA3027636A priority patent/CA3027636A1/fr
Publication of WO2017214734A1 publication Critical patent/WO2017214734A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/043—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances for fluorescence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/414—Evaluating particular organs or parts of the immune or lymphatic systems
    • A61B5/418—Evaluating particular organs or parts of the immune or lymphatic systems lymph vessels, ducts or nodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/0019—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
    • A61K49/0045—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent agent being a peptide or protein used for imaging or diagnosis in vivo
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons

Definitions

  • the present disclosure relates generally to medical illumination and imaging. More specifically, the disclosure relates to adjustable sensor mount systems and methods.
  • Optical performance of imaging systems may suffer from sensor misalignment and contamination.
  • Image quality may be especially sensitive to misalignment when using a high resolution sensor, or if the imaging optics of the system feature a large aperture.
  • Tilt-adjustable imaging sensors may fail to maintain sensor alignment for extended periods and/or over repeated use, and may be too large and bulky for compact imaging systems.
  • image quality may be adversely affected by dust and debris.
  • Sensor mounts with adjustable moving parts may further decrease optical performance by releasing debris particles due to wear in the vicinity of the sensor.
  • the adjustable sensor mounts may include a platform and a sensor assembly.
  • the sensor assembly may form a sealed, closed cavity around a sensor.
  • the platform may comprise a concave surface
  • the sensor assembly may comprise a convex surface having a corresponding and complementary shape to the concave surface of the platform.
  • the adjustable sensor mount may be configured such that the sensor can be tilted about at least one axis via movement of the sensor assembly relative to the platform.
  • the sensor may be able to be tilted about two axes.
  • the alignment of the sensor may be adjusted using one or more fasteners (e.g., screws). The one or more fasteners may be configured to tilt the sensor assembly, and thus the sensor, while being tightened and/or loosened.
  • the adjustable sensor mounts may be configured for fixation after a desired sensor alignment has been achieved.
  • the orientation of the sensor may be fixed by bonding the sensor assembly to the platform.
  • At least a portion of the sensor assembly may optionally comprise a UV-transmitting material, such as but not limited to glass, in order to allow for UV-activation of a bonding glue.
  • the glue may in some variations comprise fixed-diameter beads to maintain an invariant bond gap between the joint surfaces.
  • adjustable sensor mount systems comprising a platform and a closed cavity sensor assembly, where the closed cavity sensor assembly comprises a sensor, and the closed cavity sensor assembly is attached to the platform.
  • the adjustable sensor mount systems may comprise a first configuration in which the sensor is rotatable about at least one axis via movement of the closed cavity sensor assembly relative to the platform, and a second configuration in which the closed cavity sensor assembly is fixed relative to the platform.
  • the closed cavity sensor assembly may be fixed to the platform using fasteners (e.g., screws) and/or bonding glue.
  • the closed cavity sensor assembly may be permanently or reversibly fixed to the platform in the second configuration.
  • adjustable sensor mount systems comprising a flexure assembly and an adjustable sensor mount.
  • the adjustable sensor mount may comprise a closed cavity sensor assembly, and the closed cavity sensor assembly may comprise a sensor.
  • the closed cavity sensor assembly may be attachable to the flexure assembly, such that the sensor is configured to be tilted about at least one axis via movement of the closed cavity sensor assembly.
  • the sensor may be configured to be tilted about two axes.
  • the flexure assembly may comprise a top sensor mount plane that is configured to tilt.
  • the top sensor mount plane may tilt due to pressure applied to a side of the flexure assembly, such as applied by a screw.
  • the adjustable sensor mount may be attachable to the top sensor mount plane.
  • the adjustable sensor mount may comprise a flexure plate configured to allow tilting of the sensor.
  • the flexure plate may comprise a plurality of channels through the flexure plate.
  • the adjustable sensor mount may additionally or alternatively comprise an X-Y platform configured to allow translation of the sensor.
  • the medical imaging systems may generally comprise a laparoscope or an open field imaging head, a light source assembly configured to provide illumination to the laparoscope, and an image acquisition assembly comprising an adjustable sensor mount.
  • the adjustable sensor mount may comprise a closed cavity sensor assembly.
  • the light source assembly may comprise a visible light source and/or an excitation light source.
  • the adjustable sensor mount may further comprise a platform having a surface with a corresponding and complementary shape to a surface of the closed cavity sensor assembly.
  • the closed cavity sensor assembly may be rotatable relative to the platform.
  • the method may comprise tightening or loosening at least one of the plurality of fasteners to tilt the sensor assembly relative to the platform.
  • the method may further comprise fixing the sensor assembly to the platform after alignment.
  • the sensor assembly may be fixed using a plate, which may for example be attached to both the platform and the closed cavity sensor assembly.
  • the sensor assembly may be attached to the platform using a bonding glue.
  • the bonding glue may have fixed- diameter beads and/or be UV-activated.
  • the methods may be used for aligning a sensor of an imaging device camera assembly.
  • the imaging device camera assembly may comprise an adjustable sensor mount comprising a closed cavity sensor assembly.
  • the camera assembly may be attached to an alignment adjustment jig, and the alignment adjustment jig may be used to adjust the alignment of the closed cavity sensor assembly.
  • the alignment adjustment jig may comprise a first set of stages configured to tilt the closed cavity sensor assembly, and a second set of stages configured to translate the closed cavity sensor assembly.
  • the closed cavity sensor assembly may be fixed in place after being adjusted.
  • an adjustable sensor mount for use with an imaging system comprises: a closed cavity sensor assembly comprising a sensor, wherein the sensor is configured to be tilted about at least one axis via movement of the closed cavity sensor assembly.
  • the adjustable sensor mount further comprises a platform having a first shape, wherein the closed cavity sensor has a second shape that is corresponding and complementary to the first shape of the platform.
  • the first shape comprises a concave surface.
  • the second shape comprises a convex surface.
  • the senor is configured to be tilted about at least one axis via movement of the closed cavity sensor assembly relative to the platform.
  • the senor is configured to be tilted about two axes via movement of the closed cavity sensor assembly relative to the platform.
  • the adjustable sensor mount further comprises a fastener, wherein the fastener is configured to tilt the closed cavity sensor assembly when tightened.
  • the fastener is a screw.
  • the adjustable sensor mount further comprises a fastener, wherein the fastener is configured to tilt the closed cavity sensor assembly when loosened.
  • the fastener is a screw.
  • At least a portion of the closed cavity sensor assembly comprises a UV-transmitting material
  • At least a portion of the closed cavity sensor assembly comprises glass.
  • a first adjustable sensor mount system comprises: a closed cavity sensor assembly comprising a sensor, wherein the adjustable sensor mount system comprises a first configuration in which the sensor is rotatable about at least one axis, and wherein the adjustable sensor mount system comprises a second configuration in which the closed cavity sensor assembly is fixed.
  • the first adjustable sensor mount system further comprises a platform, wherein the sensor is rotatable in the first configuration about at least one axis via movement of the closed cavity sensor assembly relative to the platform, and wherein the closed cavity sensor assembly is fixed in the second configuration relative to the platform.
  • the closed cavity sensor assembly in the second configuration, is fixed relative to the platform using screws.
  • the closed cavity sensor assembly in the second configuration, is bonded to the platform.
  • fixed-diameter beads are located between the closed cavity sensor and the platform.
  • a first adjustable sensor mount system comprises: a flexure assembly; and an adjustable sensor mount comprising a closed cavity sensor assembly, wherein the closed cavity sensor assembly comprises a sensor, and wherein the closed cavity sensor assembly is attachable to the flexure assembly, wherein the sensor is configured to be tilted about at least one axis.
  • the sensor is configured to be tilted about at least one axis via movement of the closed cavity sensor assembly.
  • the senor is configured to be tilted about two axes.
  • the flexure assembly comprises a top sensor mount plane configured to tilt when pressure is applied to a side of the flexure assembly.
  • the closed cavity sensor assembly is attachable to the top sensor mount plane.
  • the adjustable sensor mount comprises a flexure plate configured to allow tilting of the sensor.
  • the flexure plate comprises a plurality of channels through the flexure plate.
  • the adjustable sensor mount comprises an X-Y platform configured to allow translation of the sensor.
  • a medical imaging system comprises: an imaging head; a light source assembly configured to provide illumination to the laparoscope; and an image acquisition assembly comprising an adjustable sensor mount.
  • the adjustable sensor mount comprises a closed cavity sensor assembly.
  • the adjustable sensor mount comprises a multi-chip sensor assembly comprising a prism and at least two image sensors.
  • the light source assembly comprises a visible light source and an excitation light source.
  • the adjustable sensor mount further comprises a platform having a surface with a corresponding and complementary shape to a surface of the sensor assembly, and wherein the sensor assembly is rotatable about at least one axis relative to the platform.
  • the system is an endoscopic medical imaging system and the imaging head is a laparoscope.
  • the system is an open field medical imaging system and the imaging head is an open field imaging head.
  • a first method for aligning a sensor of an imaging system comprising a platform, a closed cavity sensor assembly movably attached to the platform, and a plurality of fasteners, the first method comprising: tightening or loosening at least one of the plurality of fasteners to tilt the sensor assembly relative to the platform; and fixing the sensor assembly to the platform.
  • the sensor assembly is attached to the platform by a plate.
  • the sensor assembly is attached to the platform by bonding glue.
  • the bonding glue comprises fixed-diameter beads.
  • the bonding glue is UV-activated.
  • a second method for aligning a sensor of an imaging device camera assembly comprising: attaching the camera assembly to an alignment adjustment jig; and adjusting the alignment of the closed cavity sensor assembly, wherein adjusting the alignment of the closed cavity sensor assembly comprises at least one of tilting the closed cavity sensor assembly about an axis and translating the closed cavity sensor assembly.
  • the alignment adjustment jig comprises a first set of stages configured to tilt the closed cavity sensor assembly, and a second set of stages configured to translate the closed cavity sensor assembly.
  • the second method further comprises fixing the closed cavity sensor assembly after adjusting the alignment.
  • an alignment jig configured for aligning an adjustable sensor mount
  • the adjustable sensor mount comprises a closed cavity sensor assembly
  • the alignment jig comprising: an adjustment stage assembly configured to allow tilting and translation of the closed cavity sensor assembly.
  • the adjustment stage assembly is configured to be mounted on a set of rail.
  • the adjustment stage assembly comprises: a first set of stages configured to adjust tilt of the closed cavity sensor assembly; a second set of stages configured to adjust alignment of the closed cavity sensor assembly.
  • the first set of stages is configured such that stages in the first set are stacked with different radii, such that the stages have the same pivot point.
  • the adjustment stage assembly is configured to be held in place by compression springs.
  • the adjustment stage assembly is configured to contact the closed cavity sensor assembly via one or more kinematic balls.
  • the kinematic balls are located in indentations in a closed cavity platform of the closed cavity sensor assembly.
  • a kit for fluorescence imaging comprises an adjustable sensor mount having any one or more characteristics as described above, an adjustable sensor mount system having any one or more characteristics as described above, an adjustable sensor mount system having any one or more characteristics as described above, a medical imaging system having any one or more characteristics as described above, or an alignment jig having any one or more characteristics as described above.
  • the kit further comprises a fluorescence imaging agent.
  • a fluorescence imaging agent for medical imaging is provided for use with an adjustable sensor mount having any one or more characteristics as described above, an adjustable sensor mount system having any one or more characteristics as described above, an adjustable sensor mount system having any one or more characteristics as described above, a medical imaging system having any one or more characteristics as described above, or an alignment jig having any one or more characteristics as described above.
  • the medical imaging comprises blood flow imaging, tissue perfusion imaging, and/or lymphatic imaging comprises blood flow imaging, tissue perfusion imaging, and/or lymphatic imaging during an invasive surgical procedure, a minimally invasive surgical procedure, or during a non-invasive surgical procedure.
  • the invasive surgical procedure comprises a cardiac-related surgical procedure or a reconstructive surgical procedure.
  • the cardiac-related surgical procedure comprises a cardiac coronary artery bypass graft (CABG) procedure.
  • CABG cardiac coronary artery bypass graft
  • the CABG procedure is on pump or off pump.
  • the non-invasive surgical procedure comprises a wound care procedure.
  • the lymphatic imaging comprises identification of a lymph node, lymph node drainage, lymphatic mapping, or a combination thereof.
  • the lymphatic imaging relates to the female reproductive system.
  • an adjustable sensor mount having any one or more characteristics as described above, an adjustable sensor mount system having any one or more characteristics as described above, an adjustable sensor mount system having any one or more characteristics as described above, a medical imaging system having any one or more characteristics as described above, or an alignment jig having any one or more characteristics as described above for lymphatic imaging is provided.
  • an adjustable sensor mount having any one or more characteristics as described above, an adjustable sensor mount system having any one or more characteristics as described above, an adjustable sensor mount system having any one or more characteristics as described above, a medical imaging system having any one or more characteristics as described above, or an alignment jig having any one or more characteristics as described above for lymphatic imaging, blood flow imaging, tissue perfusion imaging, or a combination thereof is provided.
  • FIG. 1 shows an exploded view of a closed cavity sensor assembly according to an embodiment
  • FIG. 2 shows the effect on image quality of contamination on a surface of a closed cavity sensor assembly according to an embodiment
  • FIGS. 3A, 3B, and 3C-3D show exploded, front, and section views, respectively, of an adjustable sensor mount according to an embodiment
  • FIG. 3E illustrates a close-up view of a portion the sensor assembly where the closed cavity platform is fixed to the platform using bonding glue according to an embodiment
  • FIG. 3F shows an adjustable sensor mount made of a UV-transmitting material according to an embodiment
  • FIGS. 4A-4B show perspective views of a flexure assembly according to an
  • FIGS. 5A-5C show an exemplary adjustable sensor mount configured to be adjusted using a flexure plate according to an embodiment
  • FIGS. 5D-5F show the flexure plate alone according to an embodiment
  • FIG. 6A shows a variation of an endoscopic imaging system comprising an adjustable sensor mount according to an embodiment
  • FIG. 6B shows a portion of the endoscopic imaging system of FIG. 6A
  • FIG. 6C shows a variation of an open field imaging system comprising an adjustable sensor mount according to an embodiment
  • FIGS. 7A-7B show an alignment adjustment jig that may be used to align an adjustable sensor mount that is part of an imaging system according to an embodiment
  • FIG. 8 shows a section view of a multi-chip image acquisition assembly comprising a multi-chip prism with an adjustable prism mount located between the camera optics and the prism according to an embodiment
  • FIGS. 9A-9B show an alignment adjustment jig that may be used to align an adjustable sensor mount that is part of an imaging system according to an embodiment
  • FIG. 10A shows an exploded view of an alignment adjustment jig that may be used to align an adjustable sensor mount that is part of an imaging system.
  • FIG. 10B shows an adjustable sensor mount in place on the alignment adjustment jig.
  • Example embodiments will now be described more fully hereinafter with reference to the accompanying drawings; however, they may be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey exemplary implementations to those skilled in the art.
  • Various devices, systems, methods, processors, kits and imaging agents are described herein. Although at least two variations of the devices, systems, methods, processors, kits and imaging agents are described, other variations may include aspects of the devices, systems, methods, processors, kits and imaging agents described herein combined in any suitable manner having combinations of all or some of the aspects described.
  • spatially relative terms such as “beneath”, “below”, “lower”, “above”, “upper”, and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the adjustable sensor mounts described herein may comprise a closed cavity sensor assembly. This may keep dust and debris from reaching the surface of a sensor located within or enclosed by the sensor assembly, and may simplify a controlled clean room assembly process.
  • FIG. 1 shows an exploded view of a variation of a sensor assembly 120 comprising a closed cavity according to an embodiment.
  • the sensor assembly 120 may comprise a sensor/PCB assembly 125, which may be attached to or disposed or mounted on the base of a closed cavity platform 122.
  • the sensor/PCB assembly 125 may be bonded to or otherwise affixed to the base of the closed cavity platform 122.
  • the closed cavity platform 122 may comprise a front port 126, which may be covered to form a sealed sensor compartment.
  • a window 121 may be bonded to or otherwise affixed to the front port 126 to complete the sealed sensor compartment.
  • Other sensor assembly components may be located within the sealed sensor compartment. As shown in FIG. 1, for example, masks 123 and 124 may be located within the sealed sensor compartment. In some variations, the masks 123 and 124 may be placed within slots on closed cavity platform
  • the closed cavity sensor assemblies described herein may have a fixed distance between the front of the assembly (e.g., the window 121) and the sensor. It may be desirable for this distance to be as small as possible for compactness. However, contaminants on the outer window surface may have a larger effect when the distance between the window and the sensor/PCB assembly is smaller. Therefore, it may be desirable for the distance between the window and the sensor/PCB to be such that the sensor assembly is as compact as possible, while maintaining a desired image quality.
  • FIG. 2 is a diagram illustrating the effect of contamination on a surface of a sensor assembly on image quality according to an embodiment. More specifically, FIG. 2 shows a diagram of the spatial extent and magnitude of illumination intensity reduction imparted by a piece of contaminant partially obstructing light from falling on a sensor. Shown there is an illustration of a cross-section of a closed sensor assembly 200, with contaminant 202 located on a first surface 204 of a window 206 that blocks a portion of the incident light. The resultant illumination at the sensor may thus be lower in the penumbra region.
  • the illumination profile may not diminish by more than about 10% at any location on the sensor. In other variations, it may be desirable that the illumination profile not diminish by more than about 5% over the central 50% of the field of view of the sensor.
  • the shape of the contaminant may affect the magnitude of illumination intensity reduction. For instance, when front-lit with uniform intensity light at a known f-number, the drop in illumination intensity for a spherical-shaped particle having a diameter c may be equal to: where B is the distance between the first surface 204 of the window 206 and the sensor. When the particle is a flat and thin object, such as a piece of lint, the magnitude of illumination intensity reduction may be greater. The drop in illumination intensity due to a flat and thin particle having a width of c may be equal to
  • the clean room requirement may be that the maximum contaminant size is f number
  • a closed cavity sensor assembly may be insensitive to contamination having a width less than or about 50 microns. If an f/8 incidence beam is used, and the minimum distance between the window and the sensor may be about 8 mm, assuming that changes in the modulation transfer function of the imaging system of less than about 0.05% are just barely observable.
  • the closed cavity sensor assemblies described herein may be part of adjustable sensor mounts, which may allow for or facilitate precise adjustment of sensor orientation in an imaging device/system.
  • the closed cavity sensor assemblies may be adjustably supported on (e.g., affixed to) a platform. Using adjustment fasteners (e.g., screws) or alignment adjustment jigs as described herein in exemplary variations, the orientation of the sensor assembly may be adjusted relative to the platform to precisely align the sensor of the sensor assembly with an optical axis of an imaging device.
  • the closed cavity sensor assemblies may also be configured to be permanently or reversibly fixed after alignment, as described herein.
  • FIGS. 3A, 3B, and 3C-3D show exploded, front, and section views, respectively, of variation of an adjustable sensor mount 310 according to an embodiment.
  • the adjustable sensor mount 310 may comprise a sensor assembly 320 and a platform 330, which may be adjustably attached via a spherical joint allowing for tilt adjustment.
  • the sensor assembly 320 which may be a closed cavity sensor assembly as described with respect to FIG.
  • the senor assembly may comprise a concave surface and the platform may comprise a convex surface, or they may feature any suitable interfacing surfaces that may facilitate movement relative to each other in a finely adjustable manner.
  • the platform 330 may be configured to be fastened to a carriage or frame of an imaging device/system.
  • the platform 330 may comprise centering elements (e.g., holes 332) that may be used to center and fasten the platform 330 to the carriage or frame of an imaging device/system.
  • the sensor assembly 320 may be fastened to the platform 330 using, for example, a plurality of adjustment fasteners (e.g. screws 340), tension fasteners (e.g., screws 341), springs 342, kinematic balls 344, and/or kinematic slotted ball nuts 346.
  • the kinematic balls 344 and ball nuts 346 may be disposed in indentations (e.g., 60 degree conical indentations) set into the closed cavity platform 322 and the platform 330.
  • the adjustable sensor mount 310 may be configured such that tightening and/or loosening of the screws may cause rotation of the sensor about its center by moving portions of the sensor assembly 320 toward and away from the platform 330.
  • adjustable sensor mount systems may be configured for finer resolution adjustment.
  • screws with finer pitch differential may allow for finer adjustment resolution.
  • locating the adjustment screws 340 and adjustment tension screws 341 further from the center of the adjustable sensor mount 310 may allow for increased adjustment resolution, since each turn of a screw may result in a smaller change in the relative position of the sensor assembly 320 and the platform 330, and thus in a smaller change in the angle of alignment of the sensor.
  • the fasteners may be located further from the center of the adjustable sensor mount by attaching the adjustable sensor mount to an extension jig.
  • adjustable sensor mount systems may be configured for translational alignment.
  • adjustable sensor mount 310 may be mounted to allow for x-y linear translation and/or translation along the optical axis, such as by mounting to an x-y linear translation stage.
  • the x-y stage may be adjustable by integrated micrometers.
  • the adjustable sensor mount 310 may be mounted to facilitate movement along the optical axis (e.g., mounted onto a guiderail that allows for movement along the optical axis, or when the adjustable sensor 310 is mounted onto an x-y stage, the x-y stage may be mounted onto a guiderail that allows for movement along the optical axis).
  • the adjustable sensor mount systems described herein may be configured such that after the sensor (e.g., as part of a sensor/PCB assembly) is properly aligned, the sensor may be fixed in the aligned position.
  • the sensor assembly 320 following adjustment of the tilt of the sensor assembly 320 (e.g., alignment of the sensor with an imaging optical axis), the sensor assembly 320 may be fixed in a particular alignment relative to the platform 330.
  • the sensor assembly 320 may be reversibly fixed to the platform 330.
  • the sensor assembly 320 may be reversibly fixed to the platform 330 by securing the closed cavity platform 322 to the platform 330 with one or more bridge assemblies.
  • the one or more bridge assemblies may attach to both the closed cavity platform 322 and the platform 330 in order to fix their relative positions and prevent further tilt adjustment of the sensor assembly 320.
  • the bridge assemblies may comprise bridge plates 350 and bridge plate fasteners (e.g. bridge plate screws 351).
  • each bridge plate 350 may be secured by one or more bridge plate screws 351 to each of the sensor assembly 320 and the platform 330.
  • two bridge plates 350 may be disposed at opposite sides of a secured adjustable sensor mount 310.
  • Each bridge plate 350 may be attached to both the platform 330 and the closed cavity platform 322 via bridge plate fasteners (e.g., bridge plate screws 351), and may be positioned so that a normal vector passing through the center of the bridge plate's screw hole (openings) pattern also passes through the center of the image plane.
  • the bridge plates 350 may comprise holes larger than the diameter of the corresponding bridge plate screws 351 to accommodate the adjustable range of tilt of the sensor assembly 320.
  • the bridge assembly may maintain alignment of the sensor, while optionally allowing for readjustment by removal of the bridge assembly (e.g., for servicing).
  • the sensor assembly may in some variations be permanently fixed after alignment.
  • the sensor assembly may be permanently fixed to the platform by application of bonding glue between the joint surfaces. Bonding may be performed using any suitable bonding agent or technique such as, for example, using glue, epoxy, light activated glue, cold welding, electro-soldering or a combination thereof.
  • FIG. 3E illustrates a close-up view of a portion of a variation of the sensor assembly 320 where the closed cavity platform 322 is fixed to the platform 330 using bonding glue.
  • the bonding agent e.g., glue
  • the bonding agent may comprise fixed-diameter beads 352, which may maintain an invariant bond gap between the joint surfaces such that the bond gap is constant independent of steering/alignment of the sensor assembly 320.
  • bonding glue or other boding agent may be used alone for fixation, or in conjunction with other fixation methods, such as, for example, bridge plates and screws or other fasteners, as described herein.
  • the bonding may be performed such that a bond gap is substantially normal to a radial line that passes through the center of the image plane, which may require that the bonded components, such as closed cavity platform 322 and platform 330, have similar or equivalent coefficients of thermal expansion.
  • a bonding agent may be used and may function as a lubricant between the surfaces of closed cavity platform 322 and platform 330 during alignment.
  • bonding may be performed additionally, or alternatively, such that a bond gap is not substantially normal to a radial that passes through the center of the image plane.
  • bonding may be performed to bond closed cavity platform 322 and platform 330 near the location of bridge plates 350, such as by applying a bonding agent through bridge plate port 352.
  • the bond may be capable of being split after bonding to facilitate realignment, if necessary.
  • the bonding glue or bonding agent may be light activated.
  • components of the sensor assembly and/or platform may be made of a UV-transmitting material (e.g., glass), and the bonding glue or bonding agent may be a UV-activated glue/agent, as shown for example in FIG. 3F.
  • UV light may be delivered to the bonding glue/agent through the material of the sensor assembly and/or platform. This may allow for a shorter bond curing time.
  • FIGS. 4A-4B show perspective views of an exemplary flexure assembly 400 that may allow for sensor tilt adjustment in two axes.
  • the tilt of the top sensor mount plane 402 of the flexure assembly 400 may be adjusted by adjustment screws against the side of each flexure component. As shown in FIG.
  • the top sensor mount plane 402 of the flexure assembly 400 may be tilted (represented by double-headed arrow 410) about a first axis by applying force at point 406a, and tilted (represented by double-headed arrow 412) about a second axis by applying force at point 408a, with force application that may be directed normal to a thin flexure blade to facilitate prevention of undesired parasitic motion in degrees of freedom other than rotation about the desired tilt axis.
  • the top sensor mount plane 402 of the flexure assembly 400 may be tilted (represented by double-headed arrow 410) about a first axis by applying force at point 406b, and tilted (represented by double-headed arrow 412) about a second axis by applying force at point 408b.
  • Such force may be applied, for example, by adjustment fasteners (e.g., screws) against the side of each flexure component.
  • This may impart smooth flexure deformations to rotate the top sensor mount plane 402.
  • Such a design may avoid stick-slip motion (which may occur, for example, between joint surfaces), and thus may allow for/facilitate smoother motion control when making very fine alignment adjustments.
  • a top-mounted closed cavity sensor mount 414 may be mounted to the top sensor mount plane 402 of the flexure assembly 400 to allow for alignment adjustment of the sensor.
  • the bottom surfaces 404 of the flexure assembly 400 may be mounted to a rigid frame.
  • FIGS. 5A-5C show an exemplary adjustable sensor mount system configured to be adjusted using a flexure plate.
  • the adjustable sensor mount 510 may comprise a flexure plate 523, an X-Y platform 530, a closed cavity platform 522 comprising a window 521, and a sensor/PCB assembly 525.
  • FIGS. 5D-5F show the flexure plate 523.
  • the X-Y platform 530 may be bonded to an outer region 540 of the flexure plate 523, and the closed cavity platform 522 may be bonded to an inner region 541 on the flexure plate 523.
  • the outer edges of the window 521 overlying the sensor assembly 525 may be bonded to the closed cavity platform 522.
  • the flexure plate 523 may allow the sensor/PCB assembly 525 to be tilted about the x and/or y axes of the sensor, while the X-Y platform 530 may allow the sensor/PCB assembly to be translated along the x and/or y axes of the sensor.
  • the tilt of the flexure plate 523 may be adjusted by applying rotations to the sensor/PCB assembly 525 about the sensor plane using an alignment jig as described herein.
  • the inner region 541 of the flexure plate 523 may be rotated about the x and y axes relative to the outer region 540, through torsional deformation at connection points between channels 543, 545, 547, 549 in the flexure plate 523. Translations may be applied to the entire adjustable sensor mount 510 by translating the X-Y platform 530.
  • the tilt and/or translational alignment of the sensor may be fixed.
  • the tilt may be permanently set by applying potting glue inside the X-Y platform 530 to fix the closed cavity platform 522 relative to the X-Y platform 530.
  • an adjustable sensor mount system may be a component of various types of imaging systems.
  • an adjustable sensor mount system may be a component of an endoscopic imaging system, such as but not limited to an endoscopic fluorescence imaging system.
  • FIG. 6A shows an example of an endoscopic imaging system 600 that may comprise an adjustable sensor mount as described herein.
  • Imaging system 600 may comprise an illuminator 602 with a light source assembly configured to provide visible light and/or fluorescence excitation light to a surgical laparoscope 604 via a light guide 606 that is connected to the illuminator 602 via a light guide port 608.
  • a processor 610 and/or controller 620 may, in some variations, be within the same housing as the illuminator 602, as shown in FIG. 6A.
  • An image acquisition assembly 612 may receive signals via connection to the laparoscope 604, and may pass acquired images to the processor 610 via connection to the processor such as through port 614.
  • the imaging system 600 may also comprise one or more displays (e.g., computer screen or other monitor), or any suitable systems for communicating and/or storing images and image-related data.
  • an adjustable sensor mount system may be a component of an open field imaging system, such as but not limited to an open field fluorescence imaging system.
  • FIG. 6C shows an example of an open field imaging system 1600 that may comprise an adjustable sensor mount as described herein.
  • Imaging system 1600 may comprise an illuminator 1602 with a light source assembly configured to provide visible light and/or fluorescence excitation light to an open field imaging head 1604 via a light guide 1606 that is connected to the illuminator 1602 via a light guide port 1608.
  • a processor 1610 and/or controller 1620 may, in some variations, be within the same housing as the illuminator 1602, as shown in FIG. 6C.
  • Open field imaging head 1604 may comprise an image acquisition assembly 1612 which may receive signals and may pass acquired images to the processor 1610 via connection to the processor such as through port 1614.
  • the imaging system 1600 may also comprise one or more displays (e.g., computer screen or other monitor), or any suitable systems for communicating and/or storing images and image- related data.
  • the light source assembly 602 may be configured to provide fluorescence excitation light (e.g., near infrared (NIR) light) alone or in addition to visible light.
  • the light source assembly 602 (or 1602) may comprise a visible light source that emits visible light (e.g., full spectrum visible light) and an excitation light source that emits excitation light for exciting fluorophores in an object (e.g., tissue) and causing fluorescence emission.
  • the visible light source may be configured to emit visible light for illumination of the object (e.g., tissue) to be imaged.
  • the visible light source may include one or more solid state emitters, such as LEDs and/or laser diodes.
  • the visible light source may include blue, green, and red (or other color components) LEDs or laser diodes that in combination generate white light illumination.
  • These color component light sources may be centered around the same wavelengths around which the image acquisition assembly (described further herein) is centered.
  • the red, green, and blue light sources may be centered around the same wavelengths around which the RGB color filter array is centered.
  • the excitation light source may be configured to emit excitation light suitable for exciting intrinsic
  • excitation light source may include, for example, one or more LEDs, laser diodes, arc lamps, and/or illuminating technologies of sufficient intensity and appropriate wavelength to excite the fluorophores located in the object being imaged.
  • the excitation light source may be configured to emit light in the near-infrared (NIR) waveband (approximately 805 nm), though other excitation light wavelengths may be appropriate depending on the application.
  • NIR near-infrared
  • One or more of the light sources of the light source assembly 602 may be operated in a pulsed mode during the image acquisition process according to a timing scheme.
  • the excitation light source comprises a laser diode
  • power to the laser diode may be provided by, for example, a high-current laser driver, which may optionally be operated in a pulsed mode during the image acquisition process according to a timing scheme.
  • the light source assembly 602 may further comprise one or more optical elements that shape and/or guide the light output.
  • the optical components may include one or more lenses, mirrors (e.g., dichroic mirrors), light guides and/or diffractive element.
  • the output from a laser diode may be passed through one or more focusing lenses, and then through a light guide.
  • the light may be further passed through an optical diffractive element (e.g., one or more optical diffusers).
  • An optical sensor such as a solid state photodiode may be incorporated into the light source assembly and may sample the illumination intensity produced by one or more of the light sources, via scattered or diffuse reflections from the various optical elements.
  • the imaging system 600 may further comprise a processor 610.
  • the processor may be within the same housing as the light source assembly 602, as shown in FIG. 6A.
  • the processor 610 may be configured to generate real-time videos. More specifically, the processor 610 may comprise, for example, a microprocessor or other suitable central processing unit. As video frames are acquired, at least a portion of them may be stored in a memory unit for record-keeping purposes and/or retrieval for analysis.
  • the imaging system 600 may further comprise a controller, which may be embodied in, for example, a microprocessor and/or timing electronics.
  • the imaging system 1600 may further comprise a processor 1610.
  • the processor may be within the same housing as the light source assembly 1602, as shown in FIG. 6C.
  • the processor 1610 may be configured to generate real-time videos. More specifically, the processor 1610 may comprise, for example, a microprocessor or other suitable central processing unit. As video frames are acquired, at least a portion of them may be stored in a memory unit for record-keeping purposes and/or retrieval for analysis.
  • the imaging system 1600 may further comprise a controller, which may be embodied in, for example, a microprocessor and/or timing electronics.
  • the controller may control a timing scheme for the visible light source, the excitation light source, and the image acquisition assembly. This timing scheme may enable separation of the image signal associated with the reflected light and the image signal associated with the fluorescence emission light.
  • the timing scheme may involve illuminating the object with illumination light and excitation light according to a pulsing scheme, and processing the reflected light image signal and fluorescence image signal with a processing scheme, wherein the processing scheme is synchronized and matched to the pulsing scheme (e.g., via a controller) to enable separation of the two image signals in a time-division multiplexed manner.
  • pulsing and image processing schemes have been described in U.S. Patent No. 9, 173,554, filed on March 18, 2009, and titled "FMAGING SYSTEM FOR COMBINED FULL-COLOR REFLECTANCE AND NEAR-INFRARED FMAGING," the contents of which are hereby incorporated by reference in their entirety.
  • controller may be configured to control the timing scheme for the visible light source, the excitation light source, and the image acquisition assembly based at least in part on the relative movement between the image acquisition assembly and the object.
  • the image acquisition assembly 612 may acquire images using a system of optics (e.g., one or more lenses, one or more filters, one or more mirrors, beam splitters, etc.) to collect and focus light (e.g., reflected light and/or fluorescent light) onto an image sensor assembly.
  • the image acquisition assembly may be at least partially located in a camera head connected to the laparoscope 604.
  • the camera head may be connected to a processor 610 via a camera port 614.
  • the image sensor assembly may comprise at least one solid state image sensor.
  • the one or more image sensors may include, for example, a charge coupled device (CCD), a CMOS sensor, a CID, or other suitable sensor technology.
  • the image sensor assembly may include a single chip, single image sensor (e.g., a grayscale image sensor or a color image sensor having an RGB color filter array deposited on its pixels).
  • the image acquisition assembly 1612 may acquire images using a system of optics (e.g., one or more lenses, one or more filters, one or more mirrors, beam splitters, etc.) to collect and focus light (e.g., reflected light and/or fluorescent light) onto an image sensor assembly.
  • the image acquisition assembly may be at least partially located in the open field camera head 1604.
  • the open field camera head may be connected to a processor 1610 via a camera port 1614.
  • the image sensor assembly may comprise at least one solid state image sensor.
  • the one or more image sensors may include, for example, a charge coupled device (CCD), a CMOS sensor, a CID, or other suitable sensor technology.
  • the image sensor assembly may include a single chip, single image sensor (e.g., a grayscale image sensor or a color image sensor having an RGB color filter array deposited on its pixels).
  • the image sensor assembly may comprise multiple image sensors arranged, for example, on faces of a prism such as a Philips prism.
  • FIG. 8 shows an exemplary multi-chip image acquisition assembly 800 which may comprise a camera opto-mechanical assembly 818, and an adjustable sensor mount 810 for a multi-chip image sensor assembly that includes a sensor prism 822, and multiple image sensors 825, 826, and 827.
  • Each of the multiple sensors 825, 826, 827 may be bonded and sealed directly to their respective prism face, and the prism 822 may function in place of a closed cavity to facilitate preventing dust and debris from locating near to the image sensor surfaces.
  • the prism 822 may be mounted to a sensor assembly platform 820 that interfaces adjustably with a fixed platform 830.
  • the adjustable sensor mount 810 may facilitate alignment of the prism 822, and may be used with an alignment jig, bridge plates, adjustment fasteners, bonding for permanent fixation, or any other features and techniques described herein for facilitating alignment of adjustable sensor mounts.
  • the image sensor may be located within an adjustable sensor mount as described herein.
  • FIG. 6B shows an exemplary camera assembly 616, which may form part of an endoscopic imaging system 600 or an open field imaging system 1600, comprising an adjustable sensor mount.
  • the camera assembly 616 of image acquisition assembly 612 (or 1612) may comprise an adjustable sensor mount 620 and opto-mechanical assembly 618, comprising an optical system for imaging onto a sensor plane.
  • the adjustable sensor mount 620 may comprise a closed cavity sensor assembly 622 and a platform 630.
  • the closed cavity sensor assembly 622 and platform 630 may have the features described herein with respect to FIGS. 1-3F.
  • the adjustable sensor mount may have the features described herein with respect to FIGS. 5A-5D.
  • the adjustable sensor mount may have the features described herein with respect to FIG. 8.
  • the platform 630 of the adjustable sensor mount 620 may be fastened to the opto-mechanical assembly 618, and the alignment of the closed cavity sensor assembly 622 relative to platform 630 may be fixed using bridge plate 650 and bridge screws 651.
  • the adjustable sensor mount 620 may be adjusted for tilt and/or x-y alignment.
  • the adjustment fasteners e.g., screws
  • adjustment tension fasteners e.g., screws
  • the alignment of the adjustable sensor mount 620 may be fixed.
  • bridge plates 650 may be attached with bridge plate screws 651 to fix the alignment.
  • the fasteners may be removed.
  • Glue or another suitable bonding agent may optionally be used for permanent fixation (e.g., glue or another suitable bonding agent may be placed around and/or adjacent the interface between the closed cavity platform and platform, and/or introduced through a port 352 in the center of one or more bridge plates).
  • glue or another suitable bonding agent may be placed around and/or adjacent the interface between the closed cavity platform and platform, and/or introduced through a port 352 in the center of one or more bridge plates).
  • an alignment adjustment jig may be used to align an adjustable sensor mount.
  • FIGS. 7A-7B show an alignment adjustment jig that may be used to align an adjustable sensor mount that is part of an imaging system, such as but not limited to an endoscopic imaging system or an open field imaging system. Shown there is an alignment adjustment jig 700 configured to adjust the adjustable sensor mount 620 of camera assembly 616 shown in FIG. 6B.
  • FIGS. 7A-7B show the imaging device camera assembly 616 on alignment adjustment jig 700.
  • the alignment adjustment jig 700 may be configured to separately adjust tilt and x-y alignment.
  • a first set of stages 702 may be configured to adjust tilt using an Rx knob 704 and an Ry knob 706. These stages may be stacked with different radii, such that they have the same pivot point.
  • a second set of stages 708 may be configured to adjust x-y alignment using an x-translation knob 710 and a y-translation knob 712.
  • the stages 702 and 708 may form an adjustment stage assembly 720.
  • the adjustment stage assembly 720 may be mounted on a set of rails, and may be held in place against the adjustable sensor mount 620 by compression springs 722.
  • the adjustment stage assembly 720 may contact the rear of the closed cavity sensor assembly 622 via pin-mounted kinematic balls 644 (see FIG. 7B).
  • the kinematic balls 644 may be located in indentations (e.g., conical indentations) in the closed cavity platform of the sensor assembly 622.
  • the alignment of the sensor mount 620 may be fixed using a bridge assembly (e.g., fastening bridge plates 650 and bridge plate screws 651 to the sensor assembly 622 and platform 630).
  • a bridge assembly e.g., fastening bridge plates 650 and bridge plate screws 651 to the sensor assembly 622 and platform 630.
  • FIGS. 9A-B show an alternative alignment adjustment jig 900 that may be used to align an adjustable sensor mount.
  • a camera assembly of an imaging system is shown comprising an adjustable sensor mount 310, and mounted to camera holder module 910 of the alignment adjustment jig 900 via focus guides slide 912.
  • Sensor tilt adjustment module 920 is shown comprising contact pins 922 for contacting the adjustable sensor mount 310, rotational adjustment stage 924, and translational adjustment stage 926.
  • FIG. 9B shows the rail-mounted camera holder module 910 and tilt adjustment module 920 slid together so that contact pins 922 are contacting the closed cavity platform of the adjustable sensor mount 310, so that the alignment of the closed cavity platform may be adjusted by turning the rotation and translation adjustment knobs of the tilt adjustment module 920. Focus of the camera assembly may be adjusted during the sensor alignment process by sliding the camera slightly away from or toward the adjustable sensor mount 310, prior to tightly securing the fasteners affixing the adjustable sensor mount to the camera frame.
  • FIGS. 10A-B show a cylindrical alignment adjustment jig 1000 that may be used to align an adjustable sensor mount prior to sealing the closed cavity sensor assembly.
  • the alignment adjustment jig 1000 comprises a base plate 1002 including a center pin 1006, a top plate 1004 including hole 1005 that fits precisely around center pin 1006, and an alignment pin 1008.
  • an adjustable sensor mount including the closed cavity platform 122 and platform 330 may be slid over center pin 1006 of base plate 1002, so that the rear flat surface of closed cavity platform 122 sits flat on the top flat surface of base plate 1002, and alignment pin 1008 may facilitate rotational alignment of the adjustable sensor mount platforms about the center axis of the jig, as shown in FIG. 10B.
  • Hole 1005 of top plate 1004 may then be slid over center pin 1006 so that the bottom flat surface of the top plate 1004 sits flat on the top flat surface of platform 330, thus facilitating parallel alignment of the top flat surface of platform 330 and the bottom flat surface of closed cavity platform 122.
  • the platforms may be reversibly fixed using a bridge assembly (e.g., fastening bridge plates 350 and bridge plate screws 351 to the closed cavity platform 122 and platform 330), so that the platform alignment is maintained while completing assembly.
  • a bridge assembly e.g., fastening bridge plates 350 and bridge plate screws 351 to the closed cavity platform 122 and platform 330
  • further alignment adjustment may not be needed following alignment with the alignment adjustment jig 1000 and subsequent completed assembly of the adjustable sensor mount.
  • fine alignment adjustment may be performed by loosening the bridge assembly fasteners slightly and performing adjustment using any tool or jig that may allow for fine adjustment, such as the alignment adjustment jigs described in reference to FIGS. 7A-B or FIGS. 9A-B herein.
  • kits may include any part or parts of the systems described herein.
  • a kit may include any part or parts of the systems described herein and a fluorescence agent such as, for example, a fluorescence dye such as ICG or any suitable fluorescence agent or a combination of fluorescence agents.
  • a fluorescence agent is an agent which can circulate with the blood (e.g., an agent which can circulate with, for example, a component of the blood such as plasma in the blood) and which fluoresces when exposed to appropriate excitation light energy.
  • An example of the fluorescence agent is a fluorescence dye, which includes any non-toxic fluorescence dye.
  • the fluorescence dye may include a dye that emits light in the near-infrared spectrum.
  • the fluorescence dye may include a tricarbocyanine dye such as, for example, indocyanine green (ICG).
  • the fluorescence dye may comprise ICG, fluorescein isothiocyanate, rhodamine, phycoerythrin, phycocyanin, allophycocyanin, o-phthaldehyde, fluorescamine, rose Bengal, trypan blue, fluoro-gold, green fluorescence protein, flavins (e.g., riboflavin, etc.), methylene blue, porphysomes, cyanine dyes (e.g., cathepsin-activated Cy5 combined with a targeting ligand, Cy5.5, etc.), IRDye800CW, CLR 1502 combined with a targeting ligand, OTL38 combined with a targeting ligand, or a combination thereof, which is excitable using excitation light wavelengths appropriate to each imaging agent.
  • ICG fluorescein isothiocyanate
  • rhodamine phycoerythrin
  • phycocyanin allophycocyanin
  • o-phthaldehyde flu
  • an analogue or a derivative of the fluorescence imaging agent may be used.
  • a fluorescence dye analogue or a derivative may include a fluorescence dye that has been chemically modified, but still retains its ability to fluoresce when exposed to light energy of an appropriate wavelength.
  • one or more of the fluorophores giving rise to the autofluorescence may be an endogenous tissue fluorophore (e.g., collagen, elastin, NADH, etc.), 5- aminolevulinic acid (5-ALA), or a combination thereof.
  • ICG when administered to the subject, binds with blood proteins and circulates with the blood in the tissue.
  • the fluorescence imaging agent (e.g., ICG) may be administered to the subject as a bolus injection (e.g., into a vein or an artery) in a concentration suitable for imaging such that the bolus circulates in the vasculature and traverses the microvasculature.
  • a bolus injection e.g., into a vein or an artery
  • such agents may be administered simultaneously, e.g. in a single bolus, or sequentially in separate boluses.
  • the fluorescence imaging agent may be administered by a catheter.
  • the fluorescence imaging agent may be administered less than an hour in advance of performing the measurement of signal intensity arising from the fluorescence imaging agent.
  • the fluorescence imaging agent may be administered to the subject less than 30 minutes in advance of the measurement.
  • the fluorescence imaging agent may be administered at least 30 seconds in advance of performing the measurement.
  • the fluorescence imaging agent may be administered contemporaneously with performing the measurement.
  • the fluorescence imaging agent may be administered in various concentrations to achieve a desired circulating concentration in the blood.
  • the fluorescence imaging agent is ICG, it may be administered at a concentration of about 2.5 mg/mL to achieve a circulating concentration of about 5 ⁇ to about 10 ⁇ in blood.
  • the upper concentration limit for the administration of the fluorescence imaging agent is the concentration at which the fluorescence imaging agent becomes clinically toxic in circulating blood
  • the lower concentration limit is the instrumental limit for acquiring the signal intensity data arising from the fluorescence imaging agent circulating with blood to detect the fluorescence imaging agent.
  • the upper concentration limit for the administration of the fluorescence imaging agent is the concentration at which the fluorescence imaging agent becomes self-quenching.
  • the circulating concentration of ICG may range from about 2 ⁇ to about 10 mM.
  • the method comprises the step of
  • the method excludes any step of administering the imaging agent to the subject.
  • the imaging agent e.g., a fluorescence imaging agent
  • acquisition of the signal intensity data e.g., video
  • the method excludes any step of administering the imaging agent to the subject.
  • the fluorescence imaging agent may be provided as a lyophilized powder, solid, or liquid.
  • the fluorescence imaging agent may be provided in a vial (e.g., a sterile vial), which may permit reconstitution to a suitable concentration by administering a sterile fluid with a sterile syringe. Reconstitution may be performed using any appropriate carrier or diluent.
  • the fluorescence imaging agent may be reconstituted with an aqueous diluent immediately before administration.
  • any diluent or carrier which will maintain the fluorescence imaging agent in solution may be used.
  • ICG may be reconstituted with water.
  • the fluorescence imaging agent may be mixed with additional diluents and carriers.
  • the fluorescence imaging agent may be conjugated to another molecule, such as a protein, a peptide, an amino acid, a synthetic polymer, or a sugar, for example to enhance solubility, stability, imaging properties, or a combination thereof.
  • Additional buffering agents may optionally be added including Tris, HC1, NaOH, phosphate buffer, and/or HEPES.
  • the fluorescence imaging agent used in combination with the methods, systems and kits described herein may be used for blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof, which may performed during an invasive surgical procedure, a minimally invasive surgical procedure, a non-invasive surgical procedure, or a combination thereof.
  • invasive surgical procedure which may involve blood flow and tissue perfusion include a cardiac-related surgical procedure (e.g., CABG on pump or off pump) or a reconstructive surgical procedure.
  • An example of a non-invasive or minimally invasive procedure includes wound (e.g., chronic wound such as for example pressure ulcers) treatment and/or management.
  • a change in the wound over time such as a change in wound dimensions (e.g., diameter, area), or a change in tissue perfusion in the wound and/or around the peri-wound, may be tracked over time with the application of the methods and systems.
  • lymphatic imaging include identification of one or more lymph nodes, lymph node drainage, lymphatic mapping, or a combination thereof. In some variations such lymphatic imaging may relate to the female reproductive system (e.g., uterus, cervix, vulva).
  • the imaging agent(s) may be injected intravenously.
  • the imaging agent may be injected intravenously through the central venous line, bypass pump and/or cardioplegia line and/or other vasculature to flow and/or perfuse the coronary vasculature, microvasculature and/or grafts.
  • ICG may be administered as a dilute ICG/blood/saline solution down the grafted vessel or other vasculature such that the final concentration of ICG in the coronary artery or other vasculature depending on application is approximately the same or lower as would result from injection of about 2.5 mg (i.e., 1 ml of 2.5 mg/ml) into the central line or the bypass pump.
  • the ICG may be prepared by dissolving, for example, 25 mg of the solid in 10 ml sterile aqueous solvent, which may be provided with the ICG by the manufacturer.
  • One milliliter of the ICG solution may be mixed with 500 ml of sterile saline (e.g., by injecting 1 ml of ICG into a 500 ml bag of saline). Thirty milliliters of the dilute ICG/saline solution may be added to 10 ml of the subject's blood, which may be obtained in an aseptic manner from the central arterial line or the bypass pump. ICG in blood binds to plasma proteins and facilitates preventing leakage out of the blood vessels. Mixing of ICG with blood may be performed using standard sterile techniques within the sterile surgical field. Ten ml of the ICG/saline/blood mixture may be administered for each graft.
  • ICG may be administered by means of a syringe attached to the (open) proximal end of the graft.
  • a syringe attached to the (open) proximal end of the graft.
  • surgeons routinely attach an adaptor to the proximal end of the graft so that they can attach a saline filled syringe, seal off the distal end of the graft and inject saline down the graft, pressurizing the graft and thus assessing the integrity of the conduit (with respect to leaks, side branches etc.) prior to performing the first anastomosis.
  • the methods, dosages or a combination thereof as described herein in connection with cardiac imaging may be used in any vascular and/or tissue perfusion imaging applications.
  • Lymphatic mapping is an important part of effective surgical staging for cancers that spread through the lymphatic system (e.g., breast, gastric, gynecological cancers). Excision of multiple nodes from a particular node basin can lead to serious complications, including acute or chronic lymphedema, paresthesia, and/or seroma formation, when in fact, if the sentinel node is negative for metastasis, the surrounding nodes will most likely also be negative. Identification of the tumor draining lymph nodes (LN) has become an important step for staging cancers that spread through the lymphatic system in breast cancer surgery for example. LN mapping involves the use of dyes and/or radiotracers to identify the LNs either for biopsy or resection and subsequent pathological assessment for metastasis.
  • LN mapping involves the use of dyes and/or radiotracers to identify the LNs either for biopsy or resection and subsequent pathological assessment for metastasis.
  • Sentinel lymph node (SLN) mapping has emerged as an effective surgical strategy in the treatment of breast cancer. It is generally based on the concept that metastasis (spread of cancer to the axillary LNs), if present, should be located in the SLN, which is defined in the art as the first LN or group of nodes to which cancer cells are most likely to spread from a primary tumor. If the SLN is negative for metastasis, then the surrounding secondary and tertiary LN should also be negative.
  • the primary benefit of SLN mapping is to reduce the number of subjects who receive traditional partial or complete lymphadenectomy and thus reduce the number of subjects who suffer from the associated morbidities such as lymphedema and lymphocysts.
  • the current standard of care for SLN mapping involves injection of a tracer that identifies the lymphatic drainage pathway from the primary tumor.
  • the tracers used may be radioisotopes (e.g. Technetium-99 or Tc-99m) for intraoperative localization with a gamma probe.
  • the radioactive tracer technique (known as scintigraphy) is limited to hospitals with access to radioisotopes require involvement of a nuclear physician and does not provide realtime visual guidance.
  • a colored dye, isosulfan blue, has also been used, however this dye cannot be seen through skin and fatty tissue.
  • fluorescence imaging in accordance with the various embodiments for use in SLN visualization, mapping facilitates direct real-time visual identification of a LN and/or the afferent lymphatic channel intraoperatively, facilitates high-resolution optical guidance in realtime through skin and fatty tissue, visualization of blood flow, tissue perfusion or a combination thereof.
  • visualization, classification or both of lymph nodes during fluorescence imaging may be based on imaging of one or more imaging agents, which may be further based on visualization and/or classification with a gamma probe (e.g., Technetium Tc- 99m is a clear, colorless aqueous solution and is typically injected into the periareolar area as per standard care), another conventionally used colored imaging agent (isosulfan blue), and/or other assessment such as, for example, histology.
  • a gamma probe e.g., Technetium Tc- 99m is a clear, colorless aqueous solution and is typically injected into the periareolar area as per standard care
  • another conventionally used colored imaging agent isosulfan blue
  • the breast of a subject may be injected, for example, twice with about 1% isosulfan blue (for comparison purposes) and twice with an ICG solution having a concentration of about 2.5 mg/ml.
  • the injection of isosulfan blue may precede the injection of ICG or vice versa.
  • the subject under anesthesia may be injected with 0.4 ml (0.2 ml at each site) of isosulfan blue in the periareolar area of the breast.
  • the subject may be injected at 12 and 9 o'clock positions and for the left breast at 12 and 3 o'clock positions.
  • the total dose of intradermal injection of isosulfan blue into each breast may be about 4.0 mg (0.4 ml of 1% solution: 10 mg/ml).
  • the subject may receive an ICG injection first followed by isosulfan blue (for comparison).
  • ICG intradermal injection
  • a TB syringe and a 30G needle for example, the subject may be injected with about 0.1 ml of ICG (0.05 ml at each site) in the periareolar area of the breast (for the right breast, the injection may be performed at 12 and 9 o'clock positions and for the left breast at 12 and 3 o'clock positions).
  • the total dose of intradermal injection of ICG into each breast may be about 0.25 mg (0.1 ml of 2.5 mg/ml solution) per breast.
  • ICG may be injected, for example, at a rate of 5 to 10 seconds per injection.
  • the ICG When ICG is injected intradermally, the protein binding properties of ICG cause it to be rapidly taken up by the lymph and moved through the conducting vessels to the LN.
  • the ICG may be provided in the form of a sterile lyophilized powder containing 25 mg ICG with no more than 5% sodium iodide.
  • the ICG may be packaged with aqueous solvent consisting of sterile water for injection, which is used to reconstitute the ICG.
  • the ICG dose (mg) in breast cancer sentinel lymphatic mapping may range from about 0.5 mg to about 10 mg depending on the route of administration.
  • the ICG does may be about 0.6 mg to about 0.75 mg, about 0.75 mg to about 5 mg, about 5 mg to about 10 mg.
  • the route of administration may be for example subdermal, intradermal (e.g., into the periareolar region), subareolar, skin overlaying the tumor, intradermal in the areola closest to tumor, subdermal into areola, intradermal above the tumor, periareolar over the whole breast, or a combination thereof.
  • the NIR fluorescent positive LNs may be represented as a black and white NIR fluorescence image(s) for example and/or as a full or partial color (white light) image, full or partial desaturated white light image, an enhanced colored image, an overlay (e.g., fluorescence with any other image), a composite image (e.g., fluorescence incorporated into another image) which may have various colors, various levels of desaturation or various ranges of a color to highlight/visualize certain features of interest. Processing of the images may be further performed for further visualization and/or other analysis (e.g., quantification).
  • processing of the images may be further performed for further visualization and/or other analysis (e.g., quantification).
  • the lymph nodes and lymphatic vessels may be visualized (e.g., intraoperatively, in real time) using fluorescence imaging systems and methods according to the various embodiments for ICG and SLNs alone or in combination with a gamma probe (Tc-99m) according to American Society of Breast Surgeons (ASBrS) practice guidelines for SLN biopsy in breast cancer patients.
  • fluorescence imaging systems and methods according to the various embodiments for ICG and SLNs alone or in combination with a gamma probe (Tc-99m) according to American Society of Breast Surgeons (ASBrS) practice guidelines for SLN biopsy in breast cancer patients.
  • Fluorescence imaging for LNs may begin from the site of injection by tracing the lymphatic channels leading to the LNs in the axilla. Once the visual images of LNs are identified, LN mapping and identification of LNs may be done through incised skin, LN mapping may be performed until ICG visualized nodes are identified. For comparison, mapping with isosulfan blue may be performed until 'blue' nodes are identified. LNs identified with ICG alone or in combination with another imaging technique (e.g., isosulfan blue, and/or Tc-99m) may be labeled to be excised. Subject may have various stages of breast cancer (e.g., IA, IB, IIA).
  • ICG may be administered interstitially for the visualization of lymph nodes, lymphatic channels, or a combination thereof.
  • the protein binding properties of ICG cause it to be rapidly taken up by the lymph and moved through the conducting vessels to the SLN.
  • ICG may be provided for injection in the form of a sterile lyophilized powder containing 25 mg ICG (e.g., 25 mg/vial) with no more than
  • ICG may be then reconstituted with commercially available water (sterile) for injection prior to use.
  • a vial containing 25 mg ICG may be reconstituted in 20 ml of water for injection, resulting in a 1.25 mg/ml solution.
  • a total of 4 ml of this 1.25 mg/ml solution is to be injected into a subject (4 x 1 ml injections) for a total dose of
  • the cervix may also be injected four (4) times with a 1 ml solution of
  • the injection may be performed while the subject is under anesthesia in the operating room.
  • the ICG dose (mg) in gynecological cancer sentinel lymph node detection and/or mapping may range from about 0.1 mg to about 5 mg depending on the route of administration.
  • the ICG does may be about 0.1 mg to about 0.75 mg, about 0.75 mg to about 1.5 mg, about 1.5 mg to about 2.5 mg, about 2.5 mg to about 5 mg.
  • the route of administration may be for example cervical injection, vulva peritumoral injection, hysteroscopic endometrial injection, or a combination thereof.
  • mapping may be performed on a hemi- pelvis, and mapping with both isosulfan blue and ICG may be performed prior to the excision of any LNs.
  • LN mapping for Clinical Stage I endometrial cancer may be performed according to the NCCN Guidelines for Uterine Neoplasms, SLN Algorithm for Surgical Staging of
  • Endometrial Cancer; and SLN mapping for Clinical Stage I cervical cancer may be performed according to the NCCN Guidelines for Cervical Neoplasms, Surgical/SLN Mapping Algorithm for Early-Stage Cervical Cancer. Identification of LNs may thus be based on ICG fluorescence imaging alone or in combination or co-administration with for a colorimetric dye (isosulfan blue) and/or radiotracer.
  • a colorimetric dye isosulfan blue
  • Visualization of lymph nodes may be qualitative and/or quantitative. Such visualization may comprise, for example, lymph node detection, detection rate, anatomic distribution of lymph nodes. Visualization of lymph nodes according to the various embodiments may be used alone or in combination with other variables (e.g., vital signs, height, weight, demographics, surgical predictive factors, relevant medical history and underlying conditions, histological visualization and/or assessment, Tc-99m visualization and/or assessment, concomitant medications).
  • follow- up visits may occur on the date of discharge, and subsequent dates (e.g., one month).
  • Lymph fluid comprises high levels of protein, thus ICG can bind to endogenous proteins when entering the lymphatic system.
  • Fluorescence imaging e.g., ICG imaging
  • ICG imaging for lymphatic mapping when used in accordance with the methods and systems described herein offers the following example advantages: high-signal to background ratio (or tumor to background ratio) as NIR does not generate significant autofluorescence, real-time visualization feature for lymphatic mapping, tissue definition (i.e., structural visualization), rapid excretion and elimination after entering the vascular system, and avoidance of non-ionizing radiation.
  • tissue definition i.e., structural visualization
  • rapid excretion and elimination after entering the vascular system and avoidance of non-ionizing radiation.
  • NIR imaging has superior tissue penetration (approximately 5 to 10 millimeters of tissue) to that of visible light (1 to 3 mm of tissue).
  • ICG intra-operatively than blue staining (isosulfan blue) of lymph nodes.
  • the methods, dosages or a combination thereof as described herein in connection with lymphatic imaging may be used in any vascular and/or tissue perfusion imaging applications.
  • Tissue perfusion relates to the microcirculatory flow of blood per unit tissue volume in which oxygen and nutrients are provided to and waste is removed from the capillary bed of the tissue being perfused.
  • Tissue perfusion is a phenomenon related to but also distinct from blood flow in vessels.
  • Quantified blood flow through blood vessels may be expressed in terms that define flow (i.e., volume/time), or that define speed (i.e., distance/time).
  • Tissue blood perfusion defines movement of blood through micro-vasculature, such as arterioles, capillaries, or venules, within a tissue volume.
  • Quantified tissue blood perfusion may be expressed in terms of blood flow through tissue volume, namely, that of blood volume/time/tissue volume (or tissue mass).
  • Perfusion is associated with nutritive blood vessels (e.g., micro-vessels known as capillaries) that comprise the vessels associated with exchange of metabolites between blood and tissue, rather than larger-diameter non-nutritive vessels.
  • quantification of a target tissue may include calculating or determining a parameter or an amount related to the target tissue, such as a rate, size volume, time, distance/time, and/or volume/time, and/or an amount of change as it relates to any one or more of the preceding parameters or amounts.
  • a parameter or an amount related to the target tissue such as a rate, size volume, time, distance/time, and/or volume/time, and/or an amount of change as it relates to any one or more of the preceding parameters or amounts.
  • blood movement through individual capillaries can be highly erratic, principally due to vasomotion, wherein spontaneous oscillation in blood vessel tone manifests as pulsation in erythrocyte movement.
  • One or more embodiments are directed to a fluorescence imaging agent for use in the imaging systems and methods as described herein.
  • the use may comprise blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof, which may occur during an invasive surgical procedure, a minimally invasive surgical procedure, a non-invasive surgical procedure, or a combination thereof.
  • the fluorescence agent may be included in the kit described herein.
  • the invasive surgical procedure may comprise a cardiac- related surgical procedure or a reconstructive surgical procedure.
  • the cardiac-related surgical procedure may comprise a cardiac coronary artery bypass graft (CABG) procedure which may be on pump and/or off pump.
  • CABG cardiac coronary artery bypass graft
  • the minimally invasive or the non-invasive surgical procedure may comprise a wound care procedure.
  • the lymphatic imaging may comprise identification of a lymph node, lymph node drainage, lymphatic mapping, or a combination thereof.
  • the lymphatic imaging may relate to the female reproductive system.
  • Example embodiments have been disclosed herein, and although specific terms are employed, they are used and are to be interpreted in a generic and descriptive sense only and not for purpose of limitation. In some instances, as would be apparent to one of ordinary skill in the art as of the filing of the present application, features, characteristics, and/or elements described in connection with a particular embodiment may be used singly or in combination with features, characteristics, and/or elements described in connection with other embodiments unless otherwise specifically indicated. Accordingly, it will be understood by those of skill in the art that various changes in form and details may be made without departing from the spirit and scope of the present invention as set forth in the following.

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Abstract

L'invention concerne des systèmes et des procédés de montage de capteurs réglables à cavité fermée. Les systèmes de montage de capteurs comprennent une cavité fermée hermétiquement renfermant un capteur et formant un ensemble de capteur à cavité fermée. L'ensemble de capteur à cavité fermée peut être incliné et/ou déplacé en translation par rapport à une plate-forme afin de régler l'orientation du capteur pour l'aligner avec un axe optique d'imagerie. Après alignement, l'ensemble capteur à cavité fermée peut être fixé de manière permanente ou réversible en place. Les systèmes de montage de capteurs réglables à cavité fermée peuvent faire partie de systèmes d'imagerie médicale tels que des systèmes d'imagerie endoscopique et/ou des systèmes d'imagerie à champ ouvert.
PCT/CA2017/050742 2016-06-16 2017-06-16 Systèmes et procédés de montage de capteurs réglables à cavité fermée Ceased WO2017214734A1 (fr)

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EP17812366.7A EP3472570A4 (fr) 2016-06-16 2017-06-16 Systèmes et procédés de montage de capteurs réglables à cavité fermée
CA3027636A CA3027636A1 (fr) 2016-06-16 2017-06-16 Systemes et procedes de montage de capteurs reglables a cavite fermee

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US20170360309A1 (en) 2017-12-21
US11141071B2 (en) 2021-10-12
CA3027636A1 (fr) 2017-12-21
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EP3472570A1 (fr) 2019-04-24
US20220047172A1 (en) 2022-02-17

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